Class 2 Device Recall P3700 Affinity Four Birthing Bed

• Date Initiated by Firm: July 15, 2016
• Date Posted: September 08, 2016
• Recall Status: Terminated on March 23, 2017
• Recall Number: Z-2750-2016
• Recall Event ID: 74760
• 510(K)Number: K915779
• Product Classification: Table, obstetric (and accessories) - Product Code KNC
• Product: Affinity Four Birthing Bed Model P3700; ; The primary packaging is pictured below, and utilizes a metal packing brace, standard corrugated cardboard and plastic banding. When possible these beds are shipped as a quantity of two (2) together as shown with the nylon strapping. These are shipped in standard freight containers. There is no secondary packaging.
• Code Information: Affected Bed Lot Numbers: R062AA7482 R064AA7505 R042AA7318 R041AA7300 R062AA7483 R064AA7506 R042AA7320 R041AA7302 R062AA7484 R027AA7180 R042AA7321 R041AA7303 R046AA7345 R036AA7274 R042AA7323 R041AA7305 R039AA7278 R041AA7308 R042AA7324 R039AA7279 R039AA7276 R036AA7263 R039AA7281 R046AA7337 R039AA7275 R039AA7284 R046AA7346 R039AA7277 R063AA7503 R053AA7396 R061AA7475 R061AA7471 R053AA7400 R039AA7283 R061AA7472 R053AA7402 R039AA7285 R061AA7473 R053AA7404 R040AA7286 R061AA7474 R042AA7319 R039AA7282 R043AA7325 R046AA7342 R040AA7287 R043AA7327 R050AA7395 R040AA7289 R043AA7328 R056AA7443 R040AA7290 R043AA7329 R061AA7477 R040AA7292 R046AA7336 R040AA7291 R040AA7293 R046AA7339 R040AA7295 R040AA7294 R046AA7338 R041AA7301 R040AA7288 R063AA7492 R041AA7304 R040AA7296 R063AA7493 R041AA7307 R040AA7297 R063AA7494 R041AA7309 R042AA7322 R063AA7495 R041AA7310 R043AA7326 R063AA7496 R041AA7311 R043AA7330 R063AA7497 R041AA7312 R043AA7331 R063AA7498 R042AA7313 R043AA7332 R063AA7501 R042AA7314 R043AA7333 R063AA7502 R042AA7315 R041AA7298 R064AA7504 R042AA7316 R041AA7299
• Recalling Firm/ Manufacturer: Hill-Rom, Inc.; 1069 State Road 46 E; Batesville IN 47006-7520
• For Additional Information Contact: Hill-Rom Technical Support ; 800-445-3720

Manufacturer Reason
for Recall

• FDA Determined Cause: Nonconforming Material/Component
• Action: Hill-Rom Inc. initiated a voluntary recall of the Affinity Four Birthing Beds on July 15, 2016, with letters to customers mailed certified via FedEx. Customers were asked to do the following: During use, if you encounter a situation where the CPR mechanism fails to activate, the head of the bed can still be lowered, electrically, using the siderail articulation controls. A Hill-Rom representative will be contacting each facility to make arrangements for replacing the affected head drive. Please pass this notice on to all those who need to be aware within your organization and/or to any organization where the affected devices have been transferred. If you have any questions concerning this correction, please contact Hill-Rom Technical Support at 800-445-3720.
• Quantity in Commerce: 94 beds
• Distribution: US Distribution to the states of : CA, FL, IN, KS, LA, MI, MO, NC, NY, OK, OR, PA, TN, TX, WA, WY Foreign:BULGARIA, INDIA, UNITED ARAB EMIRATES
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KNC and Original Applicant = HILL-ROM, INC.